The BMJ
Effectiveness of a structured template to improve completeness of reporting randomised trial protocols: randomised controlled trial
Study Type: Randomised controlled trial (1:1, single journal, authors unaware of the study; outcome assessors masked)
Key Question: Does giving authors a SPIRIT 2025-based manuscript template during revision improve completeness of reporting in randomised trial protocols?
Key Findings:
- Completeness of reporting (0–10 scale, 11 SPIRIT items) improved by an adjusted 0.61 points more with the template (95% CI 0.20 to 1.01); mean scores rose from 5.42 to 6.70 (intervention) versus 5.77 to 6.32 (control), n=70.
- Greatest gains were in recruitment, data collection methods, and data access; median revision time was similar (27.1 vs 29.9 days).
- Of 14 survey respondents (40%), most found the template easy to use (77%) and helpful (69%), but 62% found it time-consuming.
Clinical Relevance: Better-reported protocols support critical appraisal and reduce selective reporting, which matters for GPs designing or participating in NIHR-funded primary care trials and relying on published trial evidence.
Limitations: Small, single-journal sample with only a modest absolute improvement, a low survey response rate, no harms data, and no assessment of clinical or downstream research outcomes.
